Intraforaminal O2-O3 versus Periradicular Steroidal Infiltrations in Lower Back Pain: Randomized Controlled Study
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AJNR Am J Neuroradiol 26:996–1000, May 2005
Intraforaminal O2-O3 versus Periradicular
Steroidal Infiltrations in Lower Back Pain:
Randomized Controlled Study
Matteo Bonetti, Alessandro Fontana, Biagio Cotticelli, Giorgio Dalla Volta,
Massimiliano Guindani, and Marco Leonardi
BACKGROUND AND PURPOSE: Reports about steroids and oxygen-ozone therapy to treat
lower back pain have been increasing. The purpose of our study was to compare the clinical
outcomes in patients treated with infiltrations of O2-O3 gas or steroids at short-, medium-, and
long-term follow-up.
METHODS: A total of 306 patients (166 with primarily disk disease, 140 with nondisk
vertebral disease) with acute or chronic low back and sciatic nerve pain received a CT-guided
intraforaminal infiltration of an O2-O3 gas mixture or an periradicular infiltration of steroids.
Neurologists unaware of the type of treatment assessed the patients.
RESULTS: At 1-week follow-up, most patients had a complete remission of pain, regardless
of the treatment. At 6-month follow-up, differences in favor of O2-O3 treatment were significant
in patients with disk disease (P ⴝ .0021) but not in those without disk disease (P ⴝ .0992).
Clinical outcomes were poor in 13 (15.1%) of 86 patients receiving O2-O3 infiltration and in 18
(22.5%) of 80 patients receiving steroid injection (P ⴝ .2226). Among patients without disk
disease, six (8.6%) of 70 patients receiving O2-O3 infiltration but 21.4% of the patients receiving
steroid injections had poor outcomes (P ⴝ .0332).
CONCLUSION: Oxygen-ozone treatment was highly effective in relieving acute and chronic
lower back pain and sciatica. The gas mixture can be administered as a first treatment to
replace epidural steroids.
Lower back pain with or without sciatic nerve involve- an O2-O3 gas mixture. Both methods have yielded
ment affects roughly 80% of the population at least encouraging results (3–7).
once in their lifetime. In addition, lower back pain is We compared the therapeutic effectiveness of
the leading cause of lost working days, which has a these methods, undertaking a randomized controlled
major effect on national healthcare spending (1). Un- study in 306 patients with acute or chronic low back
til 15 years ago, surgery was the treatment of choice, pain and sciatica. Patients were treated with either an
but conservative measures are now preferred in the intraforaminal infiltration of an O2-O3 gas mixture or
wake of unsatisfactory surgical outcomes (2). Among the periradicular infiltration of steroid.
the techniques adopted in the past decade to treat
sciatic nerve pain caused by a herniated disk or non- Methods
diskal spinal disease (osteophytosis, spondylolysis,
Between March 2001 and December 2003, 306 patients (178
facet joint syndrome, etc.) are the periradicular infil- men, 128 women; age range, 26 –72 years; mean age, 48 years)
tration of a steroid and the intraforaminal injection of with acute or chronic low back and sciatic nerve pain were
treated. All patients provided informed consent. Patients re-
ceived CT-guided infiltration of an O2-O3 gas mixture or a
steroid, and they were told that both were effective treatments
Received June 28, 2004; accepted after revision August 19.
according to recent findings reported in medical literature.
From the Department of Neuroradiology and Division of Neu-
rology, Istituto Clinico Città di Brescia (M.B., A.F., G.D.V.), the On their enrollment, the name, date of birth, date of enroll-
Division of Neurology, Casa di Cura S. Anna (B.C., M.G.), and the ment, date of treatment and clinical details were recorded for
Department of Neuroradiology Ospedale Bellaria, Bologna (M.L.), each patient. We recorded the type of pain, irradiation, pares-
Italy. thesias, presence of the Lasègue sign, degree of sensitivity,
Address reprint requests to Dr Matteo Bonetti, Servizio di Neu- lower limb reflexes, plantar extension of the foot, and dorsal
roradiologia, Istituto Clinico Città di Brescia, Via Gualla 15, extension of the big toe. Their records also included details
I–25123 Brescia, Italy. about the type of treatment given (steroid or O2-O3 mixture),
but this information was withheld from the neurologists per-
© American Society of Neuroradiology forming the follow-up assessment. Patients had acute or
996AJNR: 26, May 2005 INFILTRATIONS FOR BACK PAIN 997
concentration of O3 in the gas mixture (i.e., the device auto-
matically corrected the change in concentration that occurred
when the syringe was withdrawn), with constant pressure dur-
ing the O3-intake operation. We observed no toxicity effects as
the titanium, Teflon, glass, and silicon, which are inert to the
O3, were in contact with the gas (CE mark class 1B Alnitec
device [Alnitec Cremosano, Italy]).
Teams of neuroradiologists (M.B., A.F., B.C.) from two
hospitals performed the infiltrations in both groups of patients,
and two neurologists (G.D.V., M.G.) blinded to the type of
treatment performed the clinical follow-up. The neurologists
assessed the short (1-week), medium (3-month) and long-term
(6-month) outcomes of treatment by using a modified version
of the McNab method. Outcomes were classified as excellent,
which was the resolution of pain and return to activity before
the onset of pain; good or satisfactory, which was a reduction of
pain by 50% or more; or mediocre or poor, which was partial
reduction of pain by 30% or less.
For statistical analysis, the 2 test was used.
FIG 1. Preliminary CT measurements, periganglionic ap-
proach.
Results
chronic low back pain and sciatica, which was unilateral or The Table summarizes the patients’ outcomes. At
which radiated along the innervation territories of L3 (18 pa- short-term follow-up after treatment with steroid or
tients), L4 (89 patients), L5 (135 patients), or S1 (64 patients).
The duration of their symptoms was 1–20 months. Six patients
O2-O3, patients with disk disease (80% or 84.8%,
had previously received an epidural infiltration of steroids respectively) and those without disk disease (78.5%
without a notable improvement in symptoms. or 80%, respectively) had a complete remission of
Patients with bilateral lower back and sciatic nerve pain and pain. Therefore, good outcome were observed re-
those with electromyographic features of neurogenic injury gardless of the treatment, although the difference was
and/or denervation were excluded and advised to seek neuro- not statistically significant (P ⫽ .4077). At medium-
surgical treatment.
term follow-up, 77.9% of the patients with disk dis-
Before their enrollment, all patients had undergone CT or
MR imaging. On the basis of depicted neuroradiologic ease and 78.5% of those without disk disease were
changes, patients were divided into two groups: the disk-dis- pain free after O2-O3 infiltration, compared with
ease group, or those with mainly disk disease (e.g., bulging disk, 67.5% and 70%, respectively, of those treated with
protrusion or extrusion; n ⫽ 166), and the non– disk-disease steroid (P ⫽ .1318 and .2460, respectively).
group, or those with nondisk vertebral disease (e.g., osteo- At long-term follow-up, 46 (57.5%) of 80 patients
phytosis, spondylolysis, facet joints syndromes; n ⫽ 140). Of the in the disk-disease group who were treated with De-
166 patients with disk disease, 80 were treated by means of
steroid injection, whereas the remaining 86 received an infil- pomedrol deemed the clinical outcome to be excel-
tration of an O2-O3 gas mixture. Of the140 patients without lent, as did 44 (62.8%) of 70 patients in the non– disk-
disk disease, 70 received steroid injections, and 70 were re- disease group after steroid infiltration. After O2-O3
ceived infiltrations of the O2-O3 gas mixture. infiltration, 64 (74.4%) of 86 patients with disk dis-
In all patients, the injection site was disinfected, and local ease reported complete remission of pain, as did 53
anesthesia applied by using an ethyl chloride spray. Infiltrations (75.8%) of 70 patients without disk disease. Differ-
were done by specialist neuroradiologists at our institutions.
The puncture site was identified on CT scans and marked on
ences in favor of O2-O3 treatment were significant in
the patient’s skin. The distance from this point to the foramen patients with disk disease (P ⫽ .0021) but not in those
was subsequently measured (Fig 1). without disk disease (P ⫽ .0992).
A 22-gauge needle (Terumo, Leuven-Belgium) was posi- In the disk-disease group, 13 (15.1%) of 86 patients
tioned 2–3 mm from the foraminal region, close to the ganglion treated with O2-O3 infiltration, and 18 (22.5%) of 80
of the affected nerve root. A 9-cm needle was typically used, patients treated with steroid injection deemed their clin-
but longer needles were occasionally needed depending on the
ical outcome poor (P ⫽ .2226). Among patients without
size of the patient. CT scanning was performed to check correct
needle placement. This procedure was used for infiltrations of disk disease, six (8.6%) of 70 patients receiving O2-O3
both the O2-O3 mixture and the steroid (Figs 2– 4). infiltration but 21.4% of the patients receiving steroid
Infiltrations of steroid 2 mL (80 mg, Methylprednisolone injections had poor outcomes (P ⫽ .0332).
acetate; Depomedrol, Pfizer, Italy) was completed without con-
trast medium, by paying special attention to the speed of
infiltration. The procedure was completed slowly (over 1–2 Discussion
minutes) to avoid the reflux of steroid along the needle trajec-
tory. Patients with facet joint syndrome received injections into Our short-term outcomes were similar in both
the surrounding joint capsule. groups of patients, irrespective of the type of infiltra-
O2-O3 was infiltrated by injecting 3 mL of the gas mixture at tion administered. The basis of this pain relief with
a rate of 25 g/mL close to the neural foramen. The needle was steroid or O2-O3 infiltration appears to reflect be the
then retracted a few millimeters and another 5 mL of the
mixture was injected to involve the facet joint region. CT scans
origin of nerve root pain. Zennaro et al (8) reported
were used to check the correct distribution of the gas mixture that low back pain and sciatica have a neuritic origin,
in the foramen and facet joint. All treatments were performed which reduces the role of disk herniation as the sole
by using equipment allowing the photometric detection of the factor responsible for pain. In fact, episodes of back998 BONETTI AJNR: 26, May 2005
FIG 2. Infiltration of the gas mixture.
A, L4-L5 right intraextraforaminal disk herniation (arrows).
B, Correct positioning of the needle.
C, Distribution of the gas mixture in the herniation (arrowheads)
and in the facet joint (arrows).
pain and sciatica are linked to factors not strictly
connected to the mechanical compression of the
nerve root, but rather, they caused by an nonspecific
inflammatory reaction to the autoantigens of the mu-
copolysaccharide matrix located on the disk surface
and exposed to the immune system by migration of
the disk nucleus beyond the natural barrier of the
annulus fibrosus (2, 9). The inflammatory reaction is
linked to release of lytic enzymes, such as E2 prosta-
glandins and A2 phospholipase. These enzymes are
present in the peridiskal epidural adipose environ-
ment in quantities a hundred-fold higher in patients
with disk herniation than in those with a bulging disk
alone, confirming the postulated inflammatory origin
of their pain (10 –13).
In addition, larger amounts of herniated disk ma-
terial is known to be linked to faster degeneration of
the disk fragment, probably resulting from enhanced
macrophage activity triggered by the strong inflam-
matory reaction (14). The resulting inflammation af-
fects the root ganglion, namely, its nociceptive C
fibers, increasing their mechanical sensitivity and giv-
ing rise to a painful stimulus. This effect also occurs
by means of ephaptic transmission (i.e., functional
contact among neuron fibers in which impulses jump
to a contiguous inactive fiber not at the synapse but
across the membrane) in the apparent absence of FIG 3. After intraforaminal infiltration, the gas mixture is distrib-
mechanical compression (15). uted between the posterior longitudinal ligament and the dural
The rationale for anti-inflammatory treatment with sheath.AJNR: 26, May 2005 INFILTRATIONS FOR BACK PAIN 999
FIG 4. Infiltration of the gas mixture.
A, Preliminary CT measurements of L4-L5 disk herniation on the
left side.
B, Correct positioning of the needle.
C, Distribution of the gas mixture.
Results from short-, medium- and long-term follow-up
Outcome with O2-O3 Outcome with Steroid
Follow-Up and Patients Excellent Good Poor Excellent Good Poor
Short term
With disk disease (n ⫽ 166) 73 (84.8%) 8 (9.3%) 5 (5.9%) 64 (80%) 10 (12.5%) 8 (10%)
Without disk disease (n ⫽ 160) 56 (80%) 11 (15.7%) 3 (4.3%) 55 (78.5%) 9 (12.8%) 5 (7.2%)
Medium term
With disk disease (n ⫽ 166) 67 (77.9%) 9 (10.5%) 10 (11.6%) 54 (67.5%) 14 (17.5%) 12 (15%)
Without disk disease (n ⫽ 160) 55 (78.5%) 9 (12.9%) 6 (8.6%) 49 (70%) 10 (14.2%) 11 (15.8%)
Long term
With disk disease (n ⫽ 166) 64 (74.4%) 9 (10.5%) 13 (15.1%) 46 (57.5%) 16 (20%) 18 (22.5%)
Without disk disease (n ⫽ 160) 53 (75.8%) 11 (15.7%) 6 (8.6%) 44 (62.8%) 11 (15.8%) 15 (21.4%)
Note.—Data in parentheses are percentages. Short term ⫽ 1 week, medium term ⫽ 3 months, and long term ⫽ 6 months.
periganglionic steroid infiltration is the relief the Periganglionic steroid treatment by means of CT-
periganglionic inflammation by ensuring recovery of guided paraspinal infiltration is an effective tool for
the normal ganglioneural myelin sheath, and hence the relief of root pain caused by spondylosis or disk
nerve function, at the disease site (16, 17). The O2-O3 herniation, but the effects appear to be short lived
gas mixture injected proximal to the root ganglion is (25, 26). This was particularly true in patients in the
thought to normalize the levels of cytokines and pros- disk-disease group, in whom the rate of excellent
taglandins, increase superoxide dismutase levels, min- outcomes fell from 80% in the short term to 57.6% at
imize reactive oxidant species, and improve local peri- long-term follow-up. A statistically significant trend,
ganglionic circulation with a eutrophic effect on the with a relatively smooth slope, was noted in patients
nerve root (15, 18, 19). This effect was especially with disk disease group treated with O2-O3 infiltra-
evident at short-term follow-up in patients without tion, in whom the rate of excellent outcomes de-
disk disease, roughly 80% of whom reported a clear creased from 84.8% at short-term follow-up to 74.4%
improvement in symptoms; this observation demon- at long-term follow-up (P ⫽ .0021).
strating that both treatments rapidly relieve nondiskal Furthermore, undesired severe reactions, such as
pain. Our medium- and long-term results marginally arachnoiditis, meningitis, paraparesis, paraplegia,
favored O2-O3 treatment, especially in patients with sensory disorders, bowel/bladder dysfunction, head-
painful disk disease. ache and epilepsy, after steroid administration should1000 BONETTI AJNR: 26, May 2005
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